Aciclovir 200mg, 400mg
and 800mg tablets
Read all of this leaflet carefully before you start taking this medicine.
• If you have any further questions, ask you doctor or pharmacist.
• Keep this leaflet. You may need to read it again.
• If any of the side effects gets serious, or if you notice • This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
any side effects not listed in this leaflet, please tell
yours.
your doctor or pharmacist.
In this leaflet:
1. What Aciclovir is and what
it is used for
2. Before you take Aciclovir tablets
3. How to take Aciclovir tablets
4. Possible side effects
5. How to store Aciclovir tablets
6. Further information
• mycophenolate mofetil (medicine used in transplant
patients). Care should be taken if you are taking high doses
of Aciclovir, as blood levels of both drugs may increase.
• ciclosporin (an immunosuppressant drug). Your doctor
may monitor your kidney function.
• theophylline (used in asthma and other breathing
problems).
• zidovudine (used in HIV infection).
Pregnancy and breast-feeding
There is limited information on the use of Aciclovir tablets in
pregnancy or breast-feeding. Ask your doctor or pharmacist
for advice before taking this medicine.
1. What Aciclovir is and what it is used for
Driving and using machines
Aciclovir is an antiviral medicine, which acts on infected cells
by stopping the virus growing.
Aciclovir 200mg and 400mg tablets are used to:
• treat or prevent herpes simplex infections of the skin and
mucous membranes e.g. cold sores and genital herpes
(except in children whose immune system work less well
and they are unable to fight infections)
• prevent herpes simplex infections in patients whose
immune system is not working properly
• treat chicken pox (varicella infection).
Some side effects such as drowsiness and sleepiness may
impair your ability to concentrate and react. Make sure you
are not affected before you drive or operate machinery.
Sugar intolerance (200mg tablets only)
If you have been told you have an intolerance to some
sugars, contact your doctor before taking this medicine, as it
contains a type of sugar called lactose.
3. How to take Aciclovir tablets
Always take Aciclovir tablets exactly as your doctor has
told you. If you are not sure, check with your doctor or
pharmacist.
It is important to start treatment as soon as possible.
Aciclovir 800mg tablets are used to:
• treat chicken pox (varicella infection)
• treat shingles (herpes zoster infection).
2. Before you take Aciclovir tablets
Swallow the tablets with water, with or without food. If
you experience difficulty in swallowing the tablets they may
be dispersed in a glass of water (at least 50ml) which should
be stirred before drinking.
Do not take Aciclovir tablets
• if you are allergic (hypersensitive) to aciclovir, any of the
ingredients in Aciclovir tablets or valaciclovir (see section 6).
Usual doses:
• Herpes simplex infection (e.g. cold sores, genital herpes)
Adults
- treatment - 200mg 5 times a day at 4 hourly intervals for
5 days
- prevention - 200mg 4 times a day at 6 hourly intervals
for 6-12 months
- prevention in patients whose immune system is not
working properly - 200mg 4 times a day at 6 hourly
intervals for the period that the patient is at risk
- patients with severely impaired kidney function - 200mg
twice a day at 12 hourly intervals
Take special care with Aciclovir tablets
• if you have nervous system abnormalities, please tell
your doctor before you start treatment with Aciclovir
tablets.
• to avoid dehydration, it is important to drink plenty of
water whilst taking Aciclovir tablets, especially if you are
elderly or taking doses of 4g a day or higher.
• kidney problems
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Especially:
• cimetidine (used to treat peptic ulcers) and probenecid
(used to treat gout), as these increase the concentration of
aciclovir.
If your immune system is severely impaired or you have
impaired absorption from the gut, the dose may be
increased or you may be given an injection (into a vein).
Continued top of next column
50820138 AAAH1707
Continued over page
148x210 Leaflet Reel Fed Profile (BST)
Aciclovir 200mg, 400mg & 800mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date
AAAH1707
2
27.08.14
originated by:
DR
revision date:
05.09.14
revised by:
supplier:
DR
Actavis BST
dimensions:
colours/plates:
148x210
min pt size:
7pt
JDE No.:
2.
Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
4.
5.
6.
Non Printing Colours
Technical Approval
1. Profile
date sent:
technically app. date:
2.
20.08.14
50820138
1. Black
3.
pharmacode:
Aciclovir Tablets 200, 400 &
800mg x 25, 35 & 56’s (UK)
3.
Pharmacode: 3979
Date Sent:
20/08/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
[email protected]
• Herpes simplex infection (e.g. cold sores, genital herpes)
Children
- treatment • 2 years and over - adult dose
• under 2 years - half the adult dose
- prevention in patients whose immune system is not working properly • 2 years and over - adult dose
• under 2 years - half the adult dose
Rare (occurs in less than 1 in 1000 users): an increase in bilirubin
and liver related enzymes, an increase in the blood levels of urea
and creatinine, impaired kidney function which may progress to
kidney failure (usually during treatment by injection into a vein),
circular, irregular red patches on the skin of the hands and arms
(erythema multiforme), severe form of skin rash with flushing,
fever, blisters or ulcers (Stevens Johnson syndrome), severe
rash involving reddening, peeling and swelling of the skin that
resembles severe burns (toxic epidermal necrolysis).
• Herpes zoster infection (shingles)
Adults
- treatment - 800mg 5 times a day at 4 hourly intervals for 7 days
- treatment in patients with moderately impaired kidney
function - 800mg 3 times a day at 6-8 hourly intervals
- treatment in patients with severely impaired kidney function - 800mg twice a day at 12 hourly intervals
Very rare (occurs in less than one in 10,000 users): inflammation
of the liver (hepatitis), yellowing of the skin or whites of the eyes
(jaundice), changes in the numbers and types of your blood
cells (anaemia, leucopenia, thrombocytopenia). If you notice
increased bruising, nosebleeds, sore throats, infections, excessive
tiredness, breathlessness on exertion or abnormal paleness of
the skin, you should tell your doctor who may want you to have
a blood test, kidney pain (felt in the back), kidney failure, nervous
system reactions including drowsiness, confusion, seeing, hearing
or feeling things that are not there (hallucinations), psychotic
symptoms, disease of the brain, sleepiness, convulsions (fits),
coma and a feeling of general discomfort and illness, agitation,
involuntary shaking, difficulty controlling movements, difficulty
speaking.
• Varicella infection (chicken pox)
Children
- treatment - for 5 days
• 6 years and over - 800mg 4 times a day
• 2-5 years - 400mg 4 times a day
• under 2 years - 200mg 4 times a day
A liquid formulation might be more suitable for small children.
5. How to store Aciclovir tablets
Elderly
Dosage may be reduced in the elderly, especially in those whose
kidneys are not working properly.
Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Do not use Aciclovir tablets after the expiry date stated on the
label, carton or bottle. The expiry date refers to the last day of that
month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect
the environment.
To avoid dehydration, it is important to drink plenty of water
whilst taking Aciclovir tablets, especially if you are elderly or
taking doses of 4g a day or higher.
If you take more Aciclovir tablets than you should
If you take too many Aciclovir tablets, contact your doctor
immediately. Signs of an overdose include effects on the stomach
and intestines such as feeling or being sick and effects on the
nervous system such as confusion.
6. Further information
What Aciclovir tablets contain
• The active substance (the ingredient that makes the tablets
work) is aciclovir PhEur. Each tablet contains either 200mg,
400mg or 800mg of the active substance.
• The other ingredients are:
200mg tablets: lactose, magnesium stearate,
polyvidone, sodium starch glycollate, E132, E460.
400mg tablets: colloidal anhydrous silica,
magnesium stearate, polyvidone, sodium starch
glycollate, E172, E460.
800mg tablets: colloidal anhydrous silica,
magnesium stearate, polyvidone, sodium starch
glycollate, E460.
If you forget to take Aciclovir tablets
Do not take a double dose to make up for a forgotten dose. If
you forget to take a dose, take it as soon as you remember it and
then take the next dose at the right time.
4. Possible side effects
Like all medicines, Aciclovir tablets can cause side effects,
although not everybody gets them.
Contact your doctor at once if you have a severe allergic
reaction (anaphylaxis) such as swelling of the face, lips, tongue or
throat (angioedema), difficulty breathing or swallowing.
Tell your doctor or pharmacist if you notice any of the following
effects or any not listed.
What Aciclovir tablets look like and contents
of the pack
Common (occurs in less than 1 in 10 users): dizziness, headache,
feeling or being sick, diarrhoea, stomach pain, skin rashes, itching,
tiredness, sensitivity to sunlight or artificial light (e.g. sunbeds),
fever.
200mg Aciclovir tablets are blue, circular, flat bevellededge, uncoated tablets. Pack size is 25.
400mg Aciclovir tablets are pink, circular, flat bevellededge, uncoated tablets. Pack size is 56.
800mg Aciclovir tablets are white, oval, biconvex,
uncoated tablets. Pack size is 35.
Uncommon (occurs in less than 1 in 100 users): pale or red
irregular raised patches with severe itching (hives), hair loss.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in August 2014.
Continued top of next column
50820138 AAAH1707
148x210 Leaflet Reel Fed Profile (BST)
Aciclovir 200mg, 400mg & 800mg tablets PIL - UK
item no:
print proof no:
origination date:
approved for print/date
AAAH1707
2
27.08.14
originated by:
DR
revision date:
05.09.14
revised by:
supplier:
DR
Actavis BST
dimensions:
colours/plates:
148x210
min pt size:
7pt
JDE No.:
2.
Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
4.
5.
6.
Non Printing Colours
Technical Approval
1. Profile
date sent:
technically app. date:
2.
20.08.14
50820138
1. Black
3.
pharmacode:
Aciclovir Tablets 200, 400 &
800mg x 25, 35 & 56’s (UK)
3.
Pharmacode: 3979
Date Sent:
20/08/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
[email protected]